510(k) · Cleared
ClearedInjection Gold Probe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Cleared on May 15, 1996 as substantially equivalent to K942301 (Boston Scientific Corp, 1994) after a 37-day review. Its family tree reaches back 2 generations to 1985. 5 later devices descend from it.
- Decided
- May 15, 1996
- Review
- 37 days
- Class
- Class II
- Product code
- KNS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K854238 (1985). 3 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK854238 Needle W/Stylet for ImplantationMicrovasive · 1985
- 1 generation backK942301 Microvasive Injection Gold ProbeBoston Scientific Corp · 1994
- This deviceK961349 Injection Gold ProbeBoston Scientific Corp · 1996
- Descendant · cites it directly · 4 of its ownK110887 Injection Gold Probe Bipolar Electrohemostasis CatheterBoston Scientific Corporation · 2011
- Descendant · 2 generations on · 3 of its ownK133933 Injection Gold Probe Bipolar Electrohemostasis CatheterBoston Scientific Corporation · 2014
- Descendant · 3 generations on · 1 of its ownK171983 Creo Medical Electrosurgical System including Speedboat RS2 Surgical…Creo Medical, Ltd. · 2017
- Descendant · 3 generations on · 0 of its ownK232633 Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe…Boston Scientific · 2023
- Descendant · 3 generations on · 0 of its ownK192905 Creo Electrosurgical System with HS1 Hemostasis AccessoryCreo Medical, Ltd. · 2020
Most influential descendants
Showing 5 of 5 · See all- K110887Injection Gold Probe Bipolar Electrohemostasis CatheterBoston Scientific Corporation · 2011 · cites it directly4descendants
- K133933Injection Gold Probe Bipolar Electrohemostasis CatheterBoston Scientific Corporation · 2014 · 2 generations on3descendants
- K171983Creo Medical Electrosurgical System including Speedboat RS2 Surgical AccessoryCreo Medical, Ltd. · 2017 · 3 generations on1descendant
- K232633Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar…Boston Scientific · 2023 · 3 generations on0descendants
- K192905Creo Electrosurgical System with HS1 Hemostasis AccessoryCreo Medical, Ltd. · 2020 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K854238 | Needle W/Stylet for Implantation | Microvasive | 1985 | — |
| −1 | K942301 | Microvasive Injection Gold Probe | Boston Scientific Corp | 1994 | — |
| 0 (this device) | K961349 | Injection Gold Probe | Boston Scientific Corp | 1996 | — |
| +1 | K110887 | Injection Gold Probe Bipolar Electrohemostasis Catheter | Boston Scientific Corporation | 2011 | — |
| +2 | K133933 | Injection Gold Probe Bipolar Electrohemostasis Catheter | Boston Scientific Corporation | 2014 | — |
| +3 | K171983 | Creo Medical Electrosurgical System including Speedboat RS2 Surgical Accessory | Creo Medical, Ltd. | 2017 | — |
| +3 | K232633 | Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar… | Boston Scientific | 2023 | — |
| +3 | K192905 | Creo Electrosurgical System with HS1 Hemostasis Accessory | Creo Medical, Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KNS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KNS device
- #1 K241271 Aqua Medical RF Vapor Ablation Systemscore 17.2 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K942301 | Microvasive Injection Gold ProbeSummary page 3…e 3 === FIGURE 9-1: COMPARISON OF MODIFIED INJECTION GOLD PROBE AND INJECTION GOLD PROBE Modified Injection Gold Probe Injection Gold Probe (This 510(k)) (510(k) No. K942301) USE Endoscopic injection therapy and Indication electrohemostasis of zctual or potential «— Same bleeding sites in the gastro… | 1994 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110887 | Injection Gold Probe Bipolar Electrohemostasis Catheter | 2011 | 4 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 9.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K110887 (Boston Scientific Corporation, 2011) has gone furthest, with 4 descendants of its own.
How does its category compare?
All KNS devicesKNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KNS
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KNS
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KNS
14in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KNS
1,504in 2025
MAUDE reports naming product code KNS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 3 | 164 |
| 2008 | 3 | 61 | 5 | 587 |
| 2009 | 3 | 212 | 2 | 1,027 |
| 2010 | 4 | 168 | 0 | 908 |
| 2011 | 1 | — | 2 | 860 |
| 2012 | 2 | — | 0 | 848 |
| 2013 | 2 | — | 0 | 449 |
| 2014 | 1 | — | 0 | 405 |
| 2015 | 3 | 252 | 0 | 406 |
| 2016 | 3 | 30 | 6 | 457 |
| 2017 | 3 | 48 | 1 | 446 |
| 2018 | 5 | 62 | 0 | 563 |
| 2019 | 7 | 66 | 0 | 668 |
| 2020 | 4 | 212 | 0 | 906 |
| 2021 | 4 | 139 | 41 | 814 |
| 2022 | 3 | 182 | 0 | 913 |
| 2023 | 9 | 83 | 0 | 976 |
| 2024 | 3 | 198 | 14 | 1,533 |
| 2025 | 11 | 171 | 0 | 1,504 |
| 2026 | 2 | — | 4 | — |
What is it indicated for?
The Modified Injection Gold Probe and Injection Gold Probe Direct are indicated for use in endoscopic injection therapy (to deliver pharmacological injection agents, such as vasoconstrictors) and endoscopic electrohemostasis (cauterization of tissue and coagulation of blood) of actual or potential bleeding sites in the gastrointestinal tract. These sites include the following: peptic ulcers; Mallory-Weiss tears; arteriovenous malformations (AVMs); Dieulafoy lesions; bleeding polyp stocks; and angiomata. The Modified Injection Gold Probe and Injection Gold Probe Direct also have irrigation capability.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K961349 · printed Nov 6, 2026
Cite this page
510(k) Report. “K961349: Injection Gold Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961349
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026